Kornimate/medical-research-clean huggingface dataset:
effect on fenoterol metered dose inhaler on the beta-receptor population on lymphocytes in patients with bronchial asthma

Conditions: Asthma

Summary: the aim of the study was to compare the effect of fenoterol metered dose inhaler with disodium cromoglycate (dscg) metered dose inhaler on the lymphocyte β2-receptor population as well as on the clinical findings in patients with bronchial asthma over a two-week period of treatment.


Eligibility criteria:
inclusion criteria: * sex: male and female * age: 18 years or over * bronchial asthma, diagnosis confirmed by history and positive inhalation challenge test (unspecific challenge with carbachol, pd100sraw)) * severity of asthma mild to moderate or asthmatic in symptom-free intervals * raw ≤ 5 cm h2o/l/s * no antiasthmatic treatment in the week (steroid therapy: two weeks) before the start of the study exclusion criteria: * clinically significant, concomitant haematological, cardiac, renal, hepatic or metabolic diseases * intercurrent diseases, e.g. severe respiratory infections * patients who cannot do without the following preparations during the 5-week trial: * inhaled/oral steroids * theophylline * antihistamine, antiallergic drugs * inhaled/oral sympathomimetics * anticholinergics
concept: comparison of oxaliplatin vs conventional methods with calcium/magnesium in first-line metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: the primary rationale for this study is to develop an optimized schedule of administration of folfox + bevacizumab that maximizes the efficacy and safety of this regimen when administered to patients with advanced colorectal cancer. the hypothesis is that the use of an intermittent oxaliplatin (io) schedule of folfox/bevacizumab will allow these patients to continue on treatment for a longer period of time by reducing the proportion of patients who discontinue therapy early because of treatment-related toxicities and thus increasing the possibility of a longer time to progression. the primary objective is: * to test the hypothesis that an intermittent oxaliplatin (io) schedule of folfox/bevacizumab will allow patients to remain on therapy for a longer period of time compared to a conventional "treat-to-failure" schedule, by reducing the proportion of patients who discontinue therapy for treatment-related toxicities. the secondary objectives are: * to evaluate the impact of calcium/magnesium infusions on the incidence and severity of neurotoxicity in subjects receiving either the io or conventional folfox/bevacizumab treatment schedules as first-line treatment for metastatic colorectal cancer. * to evaluate the safety and efficacy of the io versus the conventional schedule + calcium and magnesium infusions, as part of oxaliplatin-based first-line therapy for metastatic colorectal cancer.


Eligibility criteria:
the following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. this information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. inclusion criteria: * histologically or cytologically documented metastatic, measurable adenocarcinoma of the colon, rectum, or appendix with no prior therapies for metastatic disease * ecog performance status (ps) of 0 or 1 * adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters * no other serious concomitant disease. exclusion criteria: * peripheral neuropathy \> grade 1 at baseline * history of significant cerebrovascular, cardiovascular, or peripheral vascular disease * uncontrolled hypertension (defined as blood pressure \> 150/100 mmhg) * history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess, within 6 months prior to start of study drug * minor surgical procedure, fine needle aspiration, or core biopsy within 7 days prior to start of study drug * serious, non-healing wound, ulcer, or bone fracture * active gastroduodenal ulcer * evidence of bleeding diathesis or coagulopathy * significant history of bleeding within 6 months prior to registration * prior history of hypertensive crisis or hypertensive encephalopathy
zanubrutinib in participants with active proliferative lupus nephritis

Conditions: Lupus Nephritis

Summary: the primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis


Eligibility criteria:
key inclusion criteria: 1. clinical diagnosis of sle according to the systemic lupus international collaborating clinics 2012 criteria. 2. isn/rps 2003 class iii/iv lupus nephritis \[type iii(a), iii (a+c), iv (a), and iv (a+c)\], with or without class v, as confirmed by a renal biopsy. 3. positive antinuclear antibodies, positive anti-dsdna autoantibody, and/or positive anti smith autoantibody at screening 4. has 24-hour urine protein excretion \> 1.0 g at screening. key exclusion criteria: exclusion criteria related to systemic lupus erythematous and other diseases: 1. glomerulonephritis caused by reasons other than systemic lupus erythematous. 2. sclerosis in \>50% of glomeruli on renal biopsy. 3. any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome. 4. severe extrarenal sle, including but not limited to severe pulmonary arterial hypertension, severe myocarditis, severe central nervous system lupus (such as neuropsychiatric sle, seizures, psychosis, transverse myelitis, central nervous system vasculitis and optic neuritis), etc. note: other protocol defined inclusion/exclusion criteria may apply.
chiropractic care, medication, and self-care for neck pain

Conditions: Neck Pain

Summary: this study will compare the effectiveness of chiropractic care, medications, and self-care on neck pain, a very common condition. the broad, long-term objective of this study is to identify effective therapies for neck pain sufferers and to increase understanding of neck pain conditions.

neck pain is very common, with considerable socioeconomic consequences. although some therapies appear promising, there are too few randomized clinical trials of sufficient quality to support the use of one therapy over another. this is especially true for acute/subacute neck pain. although commonly treated with prescription medications, neck pain sufferers are increasingly seeking relief through complementary and alternative medicine therapies, such as chiropractic spinal manipulation. little is known, however about the short- and long-term relative efficacy of these therapies and how they compare to giving patients simple advice on self-care. the broad, long-term objective of this research is to identify effective therapies for neck pain sufferers and to increase our understanding of neck pain conditions. this randomized, observer-blinded clinical trial is a unique collaborative effort by experienced chiropractic and medical researchers and will focus on patients with acute/subacute neck pain (\<12 weeks duration). the study will determine the relative efficacy of chiropractic spinal manipulation, prescription medication, and self-care advice for neck pain in both the short term (after 6 weeks) and long term (after 52 weeks), using patient-rated neck pain as the main indicator of success.

Eligibility criteria:
exclusion criteria: * pregnant women, due to use of diagnostic procedures (x-rays) and study treatments (nsaids and narcotic medications)
a study to evaluate the analgesic efficacy and safety of v120083 in subjects with osteoarthritis (oa) of the knee

Conditions: Osteo Arthritis Knee

Summary: the purpose of this study is to evaluate the analgesic efficacy of v120083 twice daily compared to placebo in subjects with moderate to severe chronic pain due to oa of the knee.


Eligibility criteria:
key inclusion criteria include: 1. males and females ≥ 40 and ≤ 80 years of age with moderate to severe chronic oa pain of the knee (lasting several hours daily) as their predominant pain condition for at least 6 months prior to screening 2. diagnostic criteria for primary pain condition (american college of rheumatology \[acr\] clinical and radiographic criteria): * at least 1 of the following in addition to knee pain: age \> 50, morning stiffness \< 30 minutes, crepitus on active motion, and * kellgren-lawrence (k-l) grade 2 or 3 radiographic evidence at the screening visit as determined by a local radiologist or rheumatologist. if a radiograph is not available, one must be taken and the diagnostic criteria must be confirmed before randomization. 3. subjects whose oa pain of the index knee is not adequately treated prior to the screening visit: * subjects must have a self-reported average pain intensity rating of moderate or severe on a verbal rating scale (ie, none, mild, moderate, and severe) over the 7 days prior to the screening visit 4. the subjects must have "average pain over the last 24 hours" scores ≥ 4 and ≤ 9 on an 11-point numerical rating scale (nrs) for the index knee on ≥ 3 consecutive days during the pain assessment period and come in for randomization within 96 hours after the latest qualifying pain score entry 5. subjects who are willing and able to stop taking any/all analgesic medications, including over-the-counter pain medications, opioids, marijuana, and topical analgesics for oa pain for the duration of the study, with the exception of study-specific rescue medication. key exclusion criteria include: 1. subjects with radiographic evidence of oa with k-l grade 0,1 or 4 2. subjects with chronic pain conditions other than oa of the knee as their predominant pain condition, including gout, pseudogout, psoriatic arthritis, active lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area 3. subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period 4. subjects with a history of a prior joint replacement of the index knee 5. subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study 6. subjects with a history of significant trauma to a knee, hip or shoulder within the previous year 7. subjects who have significant pain, other than or more than knee pain, including significant hip, back pain, that may confound the analgesic efficacy assessments of this study.

Keywords: osteoarthritis pain osteoarthritis knee
imaging for significant prostate cancer risk evaluation

Conditions: Prostate Cancer

Summary: the incidence of prostate cancer is rising however the number of deaths from prostate cancer is stable. meaning the investigators are diagnosing many men with prostate cancer that will not impact on their life. the rise in incidence is mainly due to increased use of the blood test prostate specific antigen (psa), as a screening test. currently men suspected of having prostate cancer, identified by a raised psa undergo trans-rectal ultrasound guided prostate biopsy (trus biopsy). many men have this test unnecessarily, only 1/3 being diagnosed with prostate cancer. trus biopsy is problematic as it is random and performed blind-the operator does not know where the cancer is. thus many low-risk cancers that do not need treating are diagnosed and many high risk cancers are missed or incorrectly classified. so, men with a negative biopsy or those with low risk disease are usually advised to undergo another trus biopsy. an imaging test is needed that could help men and their doctors decide whether the biopsy is a true reflection of what is inside his prostate. the investigators will test the role of two imaging tests. the first, multi-parametric magnetic resonance imaging (mp-mri) uses magnetic signals from the body to form images. the second, prostate histoscanning™ (phs) uses sound-waves. the investigators will compare the results of these tests with a detailed biopsy map-transperineal template prostate mapping biopsy (which is currently the best way to find out what is in the prostate but requires multiple biopsies to be taken under general anaesthetic. eligible men will have undergone one or more trus biopsies and who have been advised to have further tests on as part of standard of care. they will be recruited from uclh referral letters and clinics. the investigators aim is to see if either of these tests can confidently rule out the presence of clinically important disease.


Eligibility criteria:
inclusion criteria: * men who have undergone prior trans-rectal biopsies. * men undergoing further evaluation of their prostate and who are seeking characterisation using transperineal template prostate mapping biopsy. exclusion criteria: * previous history of prostate cancer treatment * men unable to have mri scan, or in whom artefact would reduce quality of mri. * men unable to have general or regional anaesthesia * men unable to give informed consent

Keywords: prostate cancer multi parametric mri prostate histoscanning transperineal prostate mapping biopsy
parent mentors using positive deviance in childhood obesity

Conditions: Obesity

Summary: a feasibility study randomizing participants (parents of children age 2-5 years old) to receive either education or a parent mentor with the aim of improving health behaviors and improving their body mass index z-score.


Eligibility criteria:
inclusion criteria: * bmi z-score \>2 exclusion criteria: * medical conditions or receiving medications affecting weight

Keywords: positive deviance peer mentors
phase 2 study evaluating mid-position strategy in radiotherapy treatment for patients with a locally advanced non-small cell lung carcinoma

Conditions: Non-small Cell Lung Cancer; Radiation Therapy; Locally Advanced Disease; Non-metastatic Disease; Non-resectable Disease

Summary: the purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4d imaging.


Eligibility criteria:
inclusion criteria: * patient with a nsclc, non-resected, non-metastatic including a parenchyma portion * age \>= 18 years * ps \<=2 * ct-scan within 3 months at inclusion * pet-scan within 3 months at inclusion * respiratory functional exploration within 3 months at inclusion * estimated v20 (by radiotherapist)\< 35% on conventional pre-radiotherapy imaging * tumor t0 to t4, m0; n1, n2 ou n3 by isolateral supra-clavicular involvement * measurable disease according to recist criteria 1.1 * curative intent chest conventional radiation therapy * radiation indication validated by a multidisciplinary meeting * adequate contraceptive method for the whole study duration and for up to 28 days after the end of radiation * mandatory affiliation with a health insurance company * patients must provide dated \& written consent exclusion criteria: * prior surgery for nsclc * nsclc nearby pulmonary apex or strictly intra-thoracic with no intra-parenchyma portion * metastatic disease or n3 contralateral lymph node * history of chest irradiation * history of known increased intrinsic radiosensibility * hypersensibility to active substance or excipient of fluoro-deoxyglucose-18f * life expectancy \< 6 months * patient with a concurrent malignancy or with a history of malignancy (excepted adequately treated basal cell skin carcinoma or cervical squamous cell carcinoma or other malignancies free of the disease for at least 5 years) * pregnant or breastfeeding women * psychological, sociological or geographical conditions that would limit compliance with study requirements * patient deprived of freedom * patient has concomitant participation to an other investigational study
return of aspiration-free swallow after laryngotracheal anesthesia

Conditions: Swallowing, Air

Summary: patients undergo laryngotracheal anesthesia (lta) for a variety of in-office laryngology procedures. prior to resolution of laryngeal sensory anesthesia, oral intake may predispose patients to aspiration. the purpose of this study is to objectively characterize a time period for return of aspiration-free swallow after lta.

swallowing is a complex process involving coordination of multiple muscle groups. sensation in the throat is very important for swallowing safely. laryngotracheal anesthetic (lta, or topical application of lidocaine anesthetic to larynx and trachea) is needed for a variety of in-office laryngology procedures, including examination of the air passage, or tracheobronchoscopy. this causes a temporary decrease in sensation that can affect swallow function and result in aspiration (passage of swallowed material into lungs instead of into esophagus and stomach). it is not known how long this effect lasts. it would be helpful to know this for counseling patients on when they can resume swallowing after a procedure. in general, most patients are advised to avoid eating/drinking for 90 minutes after their procedure to allow for sensation to return. to date, there has been no study characterizing the time required for return of aspiration-free swallow after lta.

Eligibility criteria:
inclusion criteria: * age 18 years or older * ability of patients to speak and understand english * ability for patients to consent for themselves * undergoing tracheobronchoscopy procedure for the treatment of airway stenosis * eating assessment tool (eat-10) score ≤ 3 exclusion criteria: * age less than 18 years * patients unable or unwilling to provide informed consent * women who are pregnant * history of abnormal swallowing evaluation, either videofluroscopic study of swallow or functional endoscopic evaluation of swallowing (fees) * history of medical condition affecting swallowing, such as * neurodegenerative disorders: stroke, traumatic brain injury, dementia, motor neuron disease, myasthenia gravis, cerebral palsy, gullain-barre syndrome, poliomyelitis, myopathy, parksonism, huntingon's disease, progressive supranuclear palsy, wilson's disease, vocal fold paralysis * connective tissue disorders: polymyositis, dermatomyositis, progressive systemic sclerosis, sjogren's disease, scleroderma * history of gastroesophageal tumor * history of gastroesophageal surgery * history of recent open central neck surgery (i.e., thyroidectomy, anterior cervical discectomy or fusion) * history of head and neck cancer * history of head and neck radiation therapy or chemotherapy
my care my call: peer-led health empowerment training in chronic spinal cord injury

Conditions: Spinal Cord Injuries

Summary: my care my call (mcmc) is an innovative, peer-led telephone intervention designed to empower adults with chronic spinal cord injury (sci) in the self-management of their primary health care needs to prevent secondary conditions. in a randomized controlled trial, participants assigned to the mcmc intervention receive tapered calls from a peer health coach (phc) for six months. phcs are experienced, empathetic peer mentors living with sci who act as supporters, role models, and advisors, providing goal-setting support, motivation, education, and resource referral to participants. participants complete surveys at baseline, 2, 4, and 6-months, as well as qualitative exit phone interviews. it is hypothesized that mcmc will: 1) increase participants' self-advocacy in health care interactions as reflected in increases in three domains of self-advocacy: assertiveness, illness education, and potential for mindful non-adherence, 2) increase participants' self-efficacy for health care navigation, preference for involvement in, and satisfaction with their primary care physician (pcp), and 3) increase health related quality of life and medical social support compared with those receiving usual care. additional secondary hypotheses state that the mcmc intervention will increase access to primary care and use of preventive screening services compared with those receiving usual care.


Eligibility criteria:
inclusion criteria: * self-report of physician-confirmed traumatic spinal cord injury diagnosis * injured one year ago or more * telephone access for at least 9 months * speaks and understands conversational english * have a current health issue to address exclusion criteria: * moderate to severe cognitive impairment * surgery scheduled for a 2-week or longer duration during the months of the study

Keywords: spinal cord injuries telemedicine health behaviors
the ailliance post-market clinical study

Conditions: Spinal Deformity; Spinal Degenerative Disorder; Spinal Fusion Failure; Spinal Trauma; Spinal Tumor Case

Summary: the purpose of this clinical study is to collect performance and safety data for post-market medtronic devices indicated for cranial and/or spinal indication(s). subjects are enrolled and followed postoperatively to 24 months. the ailliance clinical study is intended to collect data congruous with routine clinical care practices.


Eligibility criteria:
inclusion criteria: 1. subject provides written informed consent per institution and/or geographical requirements. 2. subject is intended to receive or be treated with an eligible medtronic cranial and spinal technology (cst) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s). 3. subject is at least 18 years of age or minimum legal age as required by local regulations. 4. subject agrees to complete all required assessments per the schedule of events. exclusion criteria: 1. subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance). 2. subject who is, or is expected to be, inaccessible for all required follow-up visits. 3. subject with exclusion criteria required by local law. 4. subject is considered vulnerable at the time of obtaining consent.
artificial intelligence in large-scale breast cancer screening

Conditions: Breast Neoplasm Female

Summary: this is a prospective clinical trial following a paired screen-positive design, with the aims to assess the performance of an artificial intelligence (ai) computer-aided detection (cad) algorithm as an independent reader, in addition to two radiologists, of screening mammograms in a true screening population. since all decisions by individual readers will be recorded, it is possible to determine what the outcome would have been had one or two of the readers not been allowed to assess images, and to determine what the outcome would have been had the recall decision been performed by consensus decision (actual) compared to single reader arbitration of discordant cases.


Eligibility criteria:
inclusion criteria: * participants in regular population-based breast cancer screening at capio st göran hospital exclusion criteria: * incomplete exam (complete exam: mediolateral oblique and craniocaudal images of left and right breast) * breast implant * complete mastectomy (excluded from screening positive group) * participant in surveillance program for prior breast cancer

Keywords: artificial intelligence breast cancer mammography screening